1. Field
The invention relates to a lancet device for puncturing the skin of mammals, in particular humans. The lancet device includes a punch element, provided with a manipulator device, and a bushing element, provided with a grip, for internally receiving the punch element in an axially displaceable relationship. The punch element, on its free end pointing away from the manipulator, carries a lancet provided with a sharp tip for deliberate puncturing of the skin. The lancet, via the punch element, and by means of a force acting in the axial direction on the free end of the bushing, is caused to enter the skin in a direction from the end of the bushing outwardly with a preadjustable force. Blocking means are provided which, once the lancet has entered the skin, prevents the lancet from being able to reenter the skin a second time.
2. Related Art
A lancet device of this kind is known (Published European Patent Application EP A 0 565 819). Many embodiments of lancet devices for puncturing the skin, particularly human skin, have long been known and have long been used with more or less good success for example in outpatient care, medical facilities, hospitals, doctors' offices, Red Cross facilities, disaster shelters, and the like, in order to obtain small quantities of blood for blood tests. The essential prerequisite for these lancet devices is that they must be capable of being produced very economically, since they are often used in great quantities by the above-listed institutions and have to be kept on hand there in large quantities as well, and they are also intended for use in Third World countries.
Another requirement of this lancet device is that at least those parts of the lancet device that directedly punch through human skin, or in other words have direct contact with the human tissue and blood located under the outer skin, must be kept absolutely sterile continuously until the lancet device is used. As a rule, these are the parts of the lancet device that are meant to penetrate the skin tissue to a predetermined depth in order to penetrate blood vessels and cause the blood to leave the entry opening of the wound, namely lancets comprising a steel body of substantially circular cross section that is sharpened on its end pointing toward the skin to be punctured.
Generic lancet devices as described above include blocking means that prevent the lancet device, once it has been used as intended, from being re-used ever again.
Lancet devices that do not have these blocking means can in principle be re-used, but this can lead to major diagnostic mistakes or, much more seriously, to infections of the user of the lancet device from germs from the previous user that were not eliminated.
For the above reasons, the trend is to employ only lancet devices that can in fact be used only once; that is, re-use, even if desired, should always be prevented by mechanical means in the lancet device, especially when it is not possible to preclude re-use of the lancet device by some groups of users. In many countries, regulations exist whereby only single-use lancet devices can be used.
The prior art lancet devices that use mechanical means to allow only a single use of the lancet device are characterized by a comparatively complex construction. While the capabilities of these known lancet devices to be tripped or used only once is typically assured, they do have a major disadvantage, namely that their production costs are considerably higher compared to lancet devices that can be used multiple times. As a result, these lancet devices that can be used only once are not used throughout the groups of users in question, even though it is intrinsically desirable, for both health reasons and health policy reasons, that they be so used by such users.